Product Wiki · Recalls · Health Canada — Medical Devices

Alinity c Processing Module (2019-04-21) — recall 44553

Health Canada — Medical Devices · Canada · 2019-05-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
44553
Date of alert
2019-05-10
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Individual cuvettes within the Alinity c cuvette segment may become seated lower than the designated height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom. A cuvette may become seated lower than the designated height due to excessive force that causes damage to the sealant around the cuvette segment top or causes the cuvette segment base to detach. Excessive force is any force greater than normal operational forces exerted by the instrument, such as during manual cleaning of cuvettes or cuvette washer movement errors. If a cuvette is lower than the designated height, there is a potential to generate falsely depressed patient results in that cuvette for any assay run on the Alinity c processing module.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alinity-c-processing-module-20

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